Recall Weekly
Serious riskFDA DeviceClass I

Arrow International kits recalled for possible sterility loss

Arrow International recalled multiple PSI and MAC catheter kits because they contain lidocaine, bupivacaine, and saline from a supplier with quality issues. The supplier's products may not be sterile, and there have been limited reports that the medications did not work as expected. If the sterility of these injectable products is compromised, patients could experience serious or life-threatening infections.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have received any of the affected kits, stop using them immediately and contact your healthcare provider or hospital pharmacy.
  2. Check the product reference number (ASK- or CDC-) and lot number on your kit against the FDA recall list.
  3. Return the kits to your supplier or pharmacy for proper disposal and replacement.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 35 products — see all of them.

Details

Units affected
72,354
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2393-2026

In the FDA's words

Description
Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU5; PSI KIT: 8.5 FR/ASK-09807-UC; PSI KIT: 9 FR X 4 1/8IN (10 CM)/ASK-09903-HH2; PSI KIT: 9 FR X 10 CM/ASK-09903-LMDTG; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-09903-OSU5; PSI KIT: 9 FR X 10 CM/CDC-09903-1A; MAC KIT: 2L 9 FR DISTAL X 11.5 CM/ASK-11242-KSF2; MAC TWO LUMEN/PSI KIT: 9 FR X 11.5 CM/ASK-11242-KSF1 AGB MAC KIT: 2L 9 FR DISTAL/ASK-21242-MCY1; MULTI LUMEN PSI KIT: 9 FR DISTAL X 4 1/2/ASK-21242-OSU4; MAC KIT: 2-L 9 FR DISTAL X 11.5 CM/ASK-21242-UCD1; 2L MAC KIT: 9 FR DISTAL X 4 IN/ASK-21142-HHC MAC KIT: 2L 9 FR DISTAL X 11.5 CM AGB/ASK-21242-LMDT; PSI KIT: 8.5 FR X 4IN (10 CM)/ASK-09804-CCH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-MM2; PSI KIT: 9 FR X 4 1/8 IN (10 CM)/ASK-29903-DU1; PSI KIT: 9 FR X 4 IN (10 CM)/ASK-29903-HHC; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-LMDT; PSI KIT: 9 FR X 4 1/8 (10 CM)/ASK-29903-NWM; PSI KIT: 9 FR X 10 CM ANTIMICROBIAL/ASK-29903-SL1; PSI KIT: 8.5 FR X 10 CM ANTIMICROBIAL/CDC-29803-XCN1A; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29803-HF6; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-29804-HHN1; MULTI LUMEN/MAC KIT: 9 FR X 4 IN (10 CM)/ASK-21142-YWH; Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. REF(Material)/UDI-DI/Lot(Batch): ASK-09701-UP/10801902143874, 10801902193275/33F23K0811, 33F24B0340, 33F24E0524, 33F24G0489, 33F25C0874, 33F25E1018, 33F25H0747, 33F25J0795, 33F26A0402, 33F26B0243, 33F26B1031; ASK-09803-OSU5/10801902193275/33F25D0761, 33F25E0533, 33F25M0683; ASK-09807-UC/10801902145847, 10801902193275/33F24B0018, 33F24F0004, 33F24J0478, 33F25C0175, 33F25E0210, 33F25E1208, 33F25G0676, 33F25L0211; ASK-09903-HH2/10801902193275/33F25E0534, 33F25G0167, 33F25H0565, 33F25J0358, 33F25M0234, 33F26C0332; ASK-09903-LMDTG/10801902193275/33F25E1184, 33F25F0112, 33F25H0375; ASK-09903-OSU5/10801902193275/33F25D0762; CDC-09903-1A/60801902116729, 10801902193275/33F24D0504, 33F24F0227, 33F24H0267, 33F24H0434, 33F24J0219, 33F24K0023, 33F24M0015, 33F24M0109, 33F25B0006, 33F25B0067, 33F25C0417, 33F25D0696, 33F25D0718, 33F25E1148, 33F25F0023, 33F25G0445, 33F25G0513, 33F25G0605, 33F25G0668, 33F26A1644; ASK-11242-KSF2/10801902193275, 10801902222500/33F25D0231, 33F25D0468, 33F25E0592, 33F25K0131, 33F26A1360, 33F26B0425; ASK-11242-KSF1/10801902193275/33F24L0840, 33F25B0190; ASK-21142-NWM/10801902193275, 10801902222746/33F25F0007, 33F25F0173, 33F25J0207, 33F25M0008, 33F26A1438, 33F26B0197; ASK-21242-MCY1/10801902193275, 10801902221022/33F24H0123, 33F25C0342, 33F25E0671, 33F25K0138, 33F26B0441; ASK-21242-OSU4/10801902193275, 10801902222562/33F25D0757, 33F25E0672, 33F25H0445, 33F25H0651, 33F25L0230, 33F26B0795; ASK-21242-UCD1/10801902193275, 10801902221633/33F25E0314, 33F25M0681, 33F26B0138; ASK-21142-HHC/10801902193275, 10801902211450/33F24L0309, 33F25C0273, 33F25G0170, 33F25H0440, 33F25J0372, 33F26B0125; ASK-21242-LMDT/10801902193275, 10801902220698/33F25C0696, 33F25E0544, 33F26A1526, 33F26B0464; ASK-09804-CCH/10801902141023, 10801902193275/33F24D0899, 33F24F0836, 33F24L0295, 33F25B0184, 33F25C0261, 33F25E0777, 33F25G0410, 33F25J0356, 33F26A1369, 33F26C0041; ASK-29803-MM2/10801902193275, 10801902221930/33F25E0549, 33F26A1352, 33F26B0176, 33F26C0031; ASK-29903-DU1/10801902193275/33F24H0139, 33F25A0171, 33F25E0553, 33F25H0426, 33F25M0012; ASK-29903-HHC/10801902193275/33F25D0235, 33F25L0263, 33F26A1431; ASK-29903-LMDT/10801902193275/33F25D0480, 33F25K0208, 33F25K0420; ASK-29903-NWM/10801902193275/33F25F0008, 33F25F0098, 33F25L0264, 33F26A1396; ASK-29903-SL1/10801902193275/33F25C0289, 33F25G0296, 33F25J0104, 33F25J0266, 33F26A1391; CDC-29803-XCN1A/10801902193114, 10801902193275/33F24E0214, 33F24F0024, 33F24F0173, 33F24F0248, 33F24G0163,33F24H0396, 33F24H0431, 33F24L0539, 33F24M0036, 33F24M0113, 33F25A0368, 33F25B0047, 33F25B0118, 33F25B0342, 33F25C0531, 33F25D0708, 33F25D0735, 33F25E1103, 33F25E1154, 33F25F0417, 33F25G0053, 33F25G0514, 33F25H0287, 33F25H0816, 33F25K0293, 33F25L0079, 33F26A1628, 33F26B0565, 33F26C0064, 33F26C0454, 33F26C0099; ASK-29803-HF6/10801902200478,10801902193275/33F24D0625, 33F24F0889, 33F24L0246, 33F25B0441, 33F25D0268, 33F25F0180, 33F25J0151, 33F25M0832; ASK-29804-HHN1/10801902193275/33F25B0236, 33F25E0550, 33F25G0691, 33F25K0053; ASK-21142-YWH/10801902135473/33F25A0440, 33F25D0030; Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR. Affected quantity: 72,354
Hazard
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

35 products in this recall

Arrow kits with lidocaine and bupivacaine recalled for sterility risk

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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